本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2311155

摘要内容如下：

背景

嗜酸性肉芽肿伴多血管炎（EGPA）是一种以嗜酸性炎症为特征的血管炎。苯雷珠单抗是一种针对嗜酸性粒细胞上表达的白细胞介素-5α受体的单克隆抗体，可能是治疗EGPA的一种选择。

方法

我们进行了一项多中心、双盲、3期、随机、活性对照的非劣效性试验，以评估苯雷珠单抗与美泊利珠单抗相比的疗效和安全性。接受标准治疗的成人复发性或难治性EGPA患者以1:1的比例随机接受苯雷珠单抗（30 mg）或美泊利珠单抗（300 mg）皮下注射，每4周一次，持续52周。主要终点是第36周和第48周的缓解（预先指定的非劣效性界值，-25个百分点）。次要终点包括累计缓解持续时间、首次复发时间、口服糖皮质激素的使用、嗜酸性粒细胞计数和安全性。

结果

共有140名患者接受了随机分组（每组70名）。在第36周和第48周，苯雷珠单抗组和美泊利珠单抗组中经校正的缓解患者百分比分别为59%和56%（差异，3个百分点；95%置信区间[CI]，-13至18；P=0.73（优效性），显示苯雷珠单抗相对于美泊利珠单抗的非劣效性，但不是优效性。两组的累计缓解时间和首次复发时间相似。在第48周至第52周期间，41%接受苯雷珠单抗治疗的患者和26%接受美泊利珠单抗治疗的患者完全停用了口服糖皮质激素。基线时，苯雷珠单抗组和美泊利珠单抗组的血液嗜酸性粒细胞计数平均值（±SD）分别为306.0±225.0每微升和384.9±563.6每微升，第52周时分别降至32.4±40.8每微升和71.8±54.4每微升。苯雷珠单抗组和美泊利珠单抗组分别有90%和96%的患者报告了不良事件。报告的严重不良事件分别为6%和13%。

结论

苯雷珠单抗在诱导复发或难治性EGPA患者缓解方面不劣于美泊利珠单抗。（由AstraZeneca资助；Mandara ClinicalTrials.gov编号，NCT04157348。）

英文原文如下：

Abstracts

BACKGROUND  Eosinophilic granulomatosis with polyangiitis (EGPA) is a vasculitis characterized by eosinophilic inflammation. Benralizumab, a monoclonal antibody against the interleukin-5α receptor expressed on eosinophils, may be an option for treating EGPA.

METHODS  We conducted a multicenter, double-blind, phase 3, randomized, active-controlled noninferiority trial to evaluate the efficacy and safety of benralizumab as compared with mepolizumab. Adults with relapsing or refractory EGPA who were receiving standard care were randomly assigned in a 1:1 ratio to receive benralizumab (30 mg) or mepolizumab (300 mg) subcutaneously every 4 weeks for 52 weeks. The primary end point was remission at weeks 36 and 48 (prespecified noninferiority margin, -25 percentage points). Secondary end points included the accrued duration of remission, time to first relapse, oral glucocorticoid use, eosinophil count, and safety.

RESULTS  A total of 140 patients underwent randomization (70 assigned to each group). The adjusted percentage of patients with remission at weeks 36 and 48 was 59% in the benralizumab group and 56% in the mepolizumab group (difference, 3 percentage points; 95% confidence interval [CI], -13 to 18; P = 0.73 for superiority), showing noninferiority but not superiority of benralizumab to mepolizumab. The accrued duration of remission and the time to first relapse were similar in the two groups. Complete withdrawal of oral glucocorticoids during weeks 48 through 52 was achieved in 41% of the patients who received benralizumab and 26% of those who received mepolizumab. The mean (±SD) blood eosinophil count at baseline was 306.0±225.0 per microliter in the benralizumab group and 384.9±563.6 per microliter in the mepolizumab group, decreasing to 32.4±40.8 and 71.8±54.4 per microliter, respectively, at week 52. Adverse events were reported in 90% of the patients in the benralizumab group and 96% of those in the mepolizumab group; serious adverse events were reported in 6% and 13%, respectively.

CONCLUSIONS  Benralizumab was noninferior to mepolizumab for the induction of remission in patients with relapsing or refractory EGPA. (Funded by AstraZeneca; MANDARA ClinicalTrials.gov number, NCT04157348.).

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